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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
| Walter Reed National Military Medical Center | FED |
| Tripler Army Medical Center | FED |
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The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.
This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of plasticity-based, adaptive, computerized cognitive remediation treatment versus a computer-based control. Both the study and the cognitive remediation treatments meet the criteria of Non-Significant Risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training, up to 65 hours |
|
| Active Comparator | Active Comparator | Commercially available computerized training, up to 65 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Plasticity-based Adaptive Cognitive Training | Other | Computerized plasticity-based adaptive cognitive training, up to 65 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function | Between-group magnitude of change in composite score with the measure constructed from Rey Auditory Verbal Learning Test (RAVLT) sum of trials 1-5 (immediate verbal memory), RAVLT delayed verbal recall, the Ruff Light Trails Test (RULIT) sum of trials 2-10 (immediate visual memory), RULIT delayed recall scores, digit span (WAIS, sum of forwards, backwards, sequencing), symbol span (WMS), anti-saccades, flanker, and set-shifting (each from the EXAMINER battery). | After three months of training |
| Change in Functional Performance | Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance. | After three months of training |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mental Health-Related Quality of Life | Between-group magnitude of change in the Mental Component Score (MCS) as measured by the SF-12v2 Health Survey. The component score is a normed-based score with a mean of 50. Scores less than 50 indicate worse mental health than the mean. | After three months of training and 3 months after training completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry W Mahncke, PhD | Posit Science Corporation | Principal Investigator |
| Cate N Stasio, BA | Posit Science Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Posit Science Corporation | San Francisco | California | 94108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10485684 | Background | Consensus conference. Rehabilitation of persons with traumatic brain injury. NIH Consensus Development Panel on Rehabilitation of Persons With Traumatic Brain Injury. JAMA. 1999 Sep 8;282(10):974-83. |
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| VA Connecticut Healthcare System |
| FED |
| VA Boston Healthcare System | FED |
| Michael E. DeBakey VA Medical Center | FED |
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| Commercially available computerized training | Other | Commercially available computerized training, up to 65 hours |
|
| Change in Physical Health-Related Quality of Life | Between-group magnitude of change in the Physical Component Score (PCS) as measured by the SF-12v2 Health Survey. The component score is a normed-based score with a mean of 50. Scores less than 50 indicate worse physical health than the mean. | After three months of training and 3 months after training completion |
| Change in Depressive Symptoms | Between-group magnitude of change in sum score using the self-report measure, Beck Depression Inventory (BDI-II). The scoring range is 0-63. Higher scores indicate more severe depressive symptoms. | After three months of training and 3 months after training completion |
| Change in PTSD Symptoms | Between-group magnitude of change in sum score using the self-report measure, PTSD Checklist - Civilian Version (PCL-C). The scoring range is 17-85. Higher scores indicate more severe PTSD symptoms. | After three months of training and 3 months after training completion |
| Change in Executive Function Symptoms | Between-group magnitude of change in After total T-score using the self-report measure, Frontal Systems Behavior Scale (FrSBe). Raw scores are converted to age- and education-corrected T-scores. The mean T-score is 50, scores greater than 65 are considered clinically significant. | After three months of training and 3 months after training completion |
| Change in Cognitive Symptoms | Between-group magnitude of change in sum score using the self-report measure, Cognitive Failures Questionnaire (CFQ). The scoring range is 0-100. Higher scores indicate more severe cognitive symptoms. | After three months of training and 3 months after training completion |
| Change in Neurobehavioral Symptoms | Between-group magnitude of change in sum score using the self-report measure, Neurobehavioral Symptoms Index (NSI). The scoring range is 0-88. Higher scores indicate more severe neurobehavioral symptoms. | After three months of training and 3 months after training completion |
| Change in TBI Functional Status | Between-group magnitude of change in overall T-score using the self-report measure, Mayo-Portland Adaptability Inventory (MPAI-4). The overall T-score range is -38 to 106. Higher scores indicate more severe TBI functional status. | After three months of training and 3 months after training completion |
| Change in Immediate Verbal Memory | Between-group magnitude of change in sum of Trials 1-5 of the Rey Auditory Verbal Learning Test (RAVLT). The scoring range is 0-75. Lower scores indicate greater impairment in immediate verbal memory. | After three months of training and 3 months after training completion |
| Change in Delayed Verbal Memory | Between-group magnitude of change in total score of delayed verbal recall on the Rey Auditory Verbal Learning Test (RAVLT). The scoring range is 0-15. Lower scores indicate greater impairment in delayed verbal memory. | After three months of training and 3 months after training completion |
| Change in Immediate Visual Memory | Between-group magnitude of change in sum of Trials 2-10 of the Ruff Light Trails Test (RULIT). The scoring range is 0-135. Lower scores indicate greater impairment in immediate visual memory. | After three months of training and 3 months after training completion |
| Change in Delayed Visual Memory | Between-group magnitude of change in total score of delayed visual recall on the Ruff Light Trails Test (RULIT). The scoring range is 0-15. Lower scores indicate greater impairment in delayed visual memory. | After three months of training and 3 months after training completion |
| Change in Short-Term Verbal Memory Span | Between-group magnitude of change in sum of forwards, backwards, and sequencing tasks of the Wechsler Adult Intelligence Scale (WAIS) 4th Edition - Digit Span. The scoring range is 0-48. Lower scores indicate greater impairment in short-term verbal memory. | After three months of training and 3 months after training completion |
| Change in Short-Term Visual Memory Span | Between-group magnitude of change in total score of the Wechsler Memory Scale (WMS) 4th Edition - Symbol Span. The scoring range is 0-50. Lower scores indicate greater impairment in short-term visual memory. | After three months of training and 3 months after training completion |
| Change in Inhibition of Reflexive Saccade | Between-group magnitude of change in total score of the Anti-Saccade task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-40. Lower scores indicate greater impairment in reflexive saccade inhibition. | After three months of training and 3 months after training completion |
| Change in Response Inhibition | Between-group magnitude of change in total score of the Flanker task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-10. Lower scores indicate greater impairment in response inhibition. | After three months of training and 3 months after training completion |
| Change in Cognitive Flexibility | Between-group magnitude of change in total score of the Set-Shifting task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-10. Lower scores indicate greater impairment in mental flexibility. | After three months of training and 3 months after training completion |
| Change in Functional Performance | Between-group magnitude of change in sum score of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance. | 3 months after training completion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
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